Status:
COMPLETED
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
Lead Sponsor:
Teva Pharmaceuticals USA
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
60-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
Detailed Description
This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 we...
Eligibility Criteria
Inclusion
- Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
- Body weight ≥50 kg and ≤90 kg
- Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
- At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA)
Exclusion
- One severe or more than two moderate vertebral fractures
- History and/or presence of hip fracture or atypical femur fracture
- Any prior treatment with denosumab
- Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
- Vitamin D deficiency or hyper- or hypocalcemiacium at screening
- Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
- Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
- Other Inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2023
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT04729621
Start Date
March 22 2021
End Date
June 19 2023
Last Update
April 18 2024
Active Locations (78)
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1
Teva Site 103
Phoenix, Arizona, United States, 85004
2
Teva Site 119
Tucson, Arizona, United States, 85704
3
Teva Site 118
San Diego, California, United States, 92111
4
Teva Site 107
New London, Connecticut, United States, 06320